X CLOSE

The U.S. Food and Drug Administration is soon expected to decide whether to approve a progesterone vaginal gel that could reduce preterm birth in women.

Cleveland-area CerviLenz, which makes a device to measure the length of a woman’s cervix, is closely watching the FDA’s decision. Approval of the drug, Prochieve 8%, could speed adoption of CerviLenz’s device, because the device could be used as a screening tool to identify candidates for the drug. A short cervix is the best predictor of preterm birth risk.

Prochieve 8% has what’s known as a PDUFA date on Sunday, Feb. 26. Essentially, that’s the day by which the FDA is expected to announce its ruling on whether the drug has been approved, but the FDA isn’t bound by the date. It could announce a decision as soon as today or, more likely, later next week.

The panel said the drug’s single trial did not show a statistically significant reduction in preterm birth among U.S. women. However, data from the phase 3 clinical trial showed the drug was associated with a 45 percent reduction in preterm births in pregnant women with a short cervix — but that data includes both U.S. and international study participants.

While that may not augur well for the drug’s approval, it’s important to note that the FDA is not bound by decisions by its panels and occasionally issues a decision counter to a panel’s recommendation.

Preterm births have been on the rise for the past 20 years in the United States and account for about 12 percent of births, according to the Centers of Disease Control and Prevention. Although KV Pharmaceuticals’ Makena was approved nearly two years ago for preterm birth in women with a history of the condition, Prochieve 8% is for women with a short cervix.

As standard clinical practice moves more toward screening all women to reduce the prevalence of preterm birth, it could hold big things for CerviLenz and the company’s simple, low-cost device.

The other method for measuring cervical length, vaginal ultrasound, isn’t used for all pregnant women, in part because it’s generally too expensive and time-consuming to be done multiple times for one pregnancy.